Cornell University Office of Research Integrity and Assurance

IRB - Human Participants Regulations

Federal Regulations

• CFR 45 Part 46, Protection of Human Subjects (revised November 13, 2001, effective December 13, 2001)
  • Subpart A, The Common Rule
  • Subpart B: Protections for Pregnant Women
  • Subpart C: Protections for Prisoners
  • Subpart D: Protections for Children
• 21 CFR 50 & 56 -- FDA regulations
• 45 CFR 160, 162 & 164 -- HIPAA

OHRP's Terms of Assurance (FWA) guidance